This study aims to retrospectively assess the safety of [225Ac]Ac-PSMA-PRLT, both as monotherapy and in combination (TANDEM) with Lutetium-177, concerning tolerance after the radiopharmaceutical administration and long-term safety, its impact on salivary glands’ function, overall survival (OS), and follow-up duration. Between December 2020 and September 2024, 89 patients received a total of 151 cycles of [225Ac]Ac-PSMA-PRLT. Patients with at least one follow-up (n = 71) were included in the analysis to evaluate xerostomia, as well as long-term hematological, renal, and hepatic toxicities, graded according to CTCAE v5.0. The most common adverse event after the radiopharmaceutical administration was flare pain (n = 16). As of the time of analysis, 68 patients had passed away (76.4%; range of survival 5 days to 39 months, median 7 months), while 21 patients were still alive (23.6%; follow-up duration: 1–33 months). Severe (G3/G4) long-term adverse events were rare, with 15 cases of G3 anemia (21.1%), 6 cases of G3 leukocytopenia (8.4%), and 14 cases of G3/G4 thrombocytopenia (19.7%). Hematological toxicity was primarily associated with severe bone marrow involvement or prior chemotherapy. Additionally, one case of G3 nephrotoxicity (1.4%) and six cases of G3 hepatotoxicity (8.4%) were observed. Only nine patients (12.7%) reported de novo xerostomia (G1/G2). In conclusion, this study demonstrates that [225Ac]Ac-PSMA PRLT, both as monotherapy and combined with [177Lu]Lu-PSMA as TANDEM PRLT, is generally safe in terms of both tolerance after the radiopharmaceutical administration and long-term toxicity.
本研究旨在回顾性评估[225Ac]Ac-PSMA-PRLT作为单药治疗以及与镥-177联合（TANDEM）治疗的安全性，重点关注放射性药物给药后的耐受性、长期安全性、对唾液腺功能的影响、总生存期（OS）及随访时长。2020年12月至2024年9月期间，共89例患者接受了总计151个周期的[225Ac]Ac-PSMA-PRLT治疗。为评估口干症及长期血液学、肾脏和肝脏毒性，纳入至少完成一次随访的患者（n=71），所有毒性反应均按CTCAE v5.0标准分级。放射性药物给药后最常见的不良事件为爆发痛（n=16）。截至分析时，68例患者已死亡（76.4%；生存期范围5天至39个月，中位7个月），21例患者仍存活（23.6%；随访时长：1-33个月）。严重（G3/G4）长期不良事件发生率较低，其中G3贫血15例（21.1%）、G3白细胞减少6例（8.4%）、G3/G4血小板减少14例（19.7%）。血液学毒性主要与严重骨髓受累或既往化疗史相关。此外，观察到G3肾毒性1例（1.4%）和G3肝毒性6例（8.4%）。仅9例患者（12.7%）报告新发口干症（G1/G2）。综上所述，本研究表明无论是作为单药治疗还是与[177Lu]Lu-PSMA联合的TANDEM PRLT方案，[225Ac]Ac-PSMA PRLT在放射性药物给药后的耐受性和长期毒性方面总体安全性良好。
肿瘤(癌症)患者之家